Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

Completed · Phase 3

Conditions studied: Pain, Diabetic Neuropathy

In brief

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

Key facts

Study ID

NCT00113620

Run by

Avanir Pharmaceuticals

People needed

450

Starts

2005-07-01

Expected to finish

2007-02-01

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus
• Established diabetic therapy for at least 3 months
• Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
• Pain the previous three months
• Not pregnant

You may not qualify if…

• Patient failed adequate trial of 3 or more medications or has required narcotics for pain
• History of torsades de pointes
• Sensitivity to quinidine or opiate drugs (codeine, etc)
• Severe pain that could confound the assessment
• Patient has had any amputations
• Patient has participated in the past 30 days or is currently participating in another trial
• Patient has previously received treatment with dextromethorphan and quinidine

Where it is running

• Pivotal Research Centers — Mesa, Arizona, United States
• Dedicate Clinical Research, Inc. — Sun City, Arizona, United States
• Central Arkansas Research — Hot Springs, Arkansas, United States
• Research Solutions — Jonesboro, Arkansas, United States
• Bay Area Foot Care — Castro Valley, California, United States
• South Bay Clinical Research Inc. — Inglewood, California, United States
• Pacific Sleep Medicine Services, Inc. — Los Angeles, California, United States
• Pacific Sleep Medicine Services, Inc. — Palm Springs, California, United States
• Northern California Research Group — Sacramento, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• University Clinical Research - DeLand — DeLand, Florida, United States
• The Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• FPA Clinical Research — Kissimmee, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• Neurology Clinical Research, Inc. — Sunrise, Florida, United States
• Laszlo J. Mate, MD — West Palm Beach, Florida, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Medisphere Medical Research Center, LLC — Evansville, Indiana, United States
• Investigative Clinical Reserach of Indiana, LLC — Indianapolis, Indiana, United States
• Crossroads Research, Inc. — Owings Mills, Maryland, United States
• Medex Healthcare Research, Inc. — St Louis, Missouri, United States
• Radiant Research - St. Louis — St Louis, Missouri, United States
• Montana Neuroscience Institute — Missoula, Montana, United States
• Creighton Diabetes Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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